Monitoring various vital signs of a patient has been an important aspect of hospital patient care, especially for patients with diseases at advanced stages, suffering from severe trauma, or in other emergency settings. Additionally, outpatient monitoring of various physiological conditions are being increasingly used for evaluation of patient health conditions as well as early detection and treatment of heart diseases, diabetes, and other diseases. For example, an electrocardiogram (ECG or EKG) can be used to evaluate the heart condition of a patient, where electrodes are placed at certain locations on the chest, arms, and/or legs. These electrodes can be connected to an ECG machine by lead wires, and the electric signals received by the ECG machine can be analyzed and displayed for the physician's information and further interpretation.
Attempts have also been made to develop systems to improve a patient's comfort, freedom and privacy by decreasing the number and volume of devices directly or indirectly attached to the patient. For example, U.S. Pat. No. 7,979,111 discloses a wireless electrode arrangement and method for patient monitoring, where a plurality of wireless electrodes suitable for attachment to the surface of the body of a patient are capable of continuously monitoring of a subject wirelessly. Copending U.S. patent application Ser. No. 13/835,049 (published as U.S. Patent Application Publication No. 20130204100) further describes a network of wireless sensors for monitoring hemodynamic parameters of a subject. The disclosures of both of these documents are incorporated in its entirety by reference herein.
Implantable devices such as implantable cardioverter defibrillators (ICDs) or pacemakers are often indicated for patients who have or are at increased risk for various heart conditions related to the heart's electrical system, such as ventricular and atrial arrhythmias including but not limited to ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and bradycardia, etc. These implantable devices can monitor and/or manage certain heart conditions of the patients and prevent or control heart episodes that would otherwise interfere with daily life or be life threatening, and can therefore allow patients with certain heart conditions to carry on their normal lives with relatively few restrictions and generally low level of discomfort.
However, there can be limiting factors for these implantable devices such as inaccuracy in detecting the relevant heart condition episodes and administering appropriate therapies. For example, the positioning and contact of the leads of the ICDs with the heart muscle can be affected by the patient's movement, and the problem is more acute for young and more active patients. ICDs can also have lead failures after being worn by a patient for an extended period of time, e.g., a number of years. Lead positioning errors and failures can cause inaccurate or distorted electrograms, and thereby may lead to insufficient, overly aggressive, or otherwise inappropriate cardiac intervention, such as excessive number of unwarranted shocks or shocks with unnecessarily large magnitude, which can cause discomfort, pain, and other undesirable effects on the quality of life of the patients.
Since the last decade, and especially after the enactment of the American Recovery and Reinvestment Act of 2009, healthcare providers are facing more regulations regarding electronic record management (EMR) and electronic health records (EHR) (or personal health record (PHR)). Meanwhile, medical software providers have been developing a plethora of systems that facilitate electronic data storage and management to enable healthcare providers to be in compliance with such increased regulations. For example, a patient's EHR can provide a longitudinal electronic record of patient health information gathered during one or more encounters in a care delivery setting, which can include information such as patient demographics, medications, vital signs, medical history, laboratory test results, and radiology reports, etc. The EHR can also be used to provide decision support, quality management, and outcomes reporting.
There is a need for a system that integrates the real time monitoring capability of wireless sensors worn by a patient with the data storage and processing capabilities afforded by electronic health records management systems for personalized monitoring and clinical decision support, improving accuracy in diagnosis and validating treatment options proposed by physicians.